Primary research questions | |
Is the intervention feasible and acceptable to staff and participants?  • Is the time commitment required for staff to monitor the intervention and participants to partake in the intervention feasible?  • Are there any environmental barriers to completion of the intervention?  • Is the content of the intervention acceptable to participants and staff?  • Do the participants adhere to the intervention and what adherence issues arise?  • What are the components of usual care for participants allocated to the control group? | |
Are the outcome measures feasible and acceptable to participants?  • What is the required time and number of visits required to collect each outcome from participants?  • Are the outcome measures acceptable to participants?  • What is the level of missing data within the self-reported outcome measures?  • What is the feasibility of collecting health economic data (i.e. sources used and time taken)? | |
What is the required sample size for a definitive RCT?  • What is the baseline score and variability of the primary outcome measure among participants?  • What is the estimated effect size and variance for the primary outcome measure?  • What are the recruitment and attrition rates for nursing homes and participants? Do these rates differ between the intervention and control groups? | |
Secondary research questions | |
What are the preliminary clinical outcomes and cost-effectiveness of the intervention compared to the control group?  • What are the estimated outcomes of the intervention in comparison with the control group and are these sustained at 12-month follow-up?  • What are the costs of the intervention in comparison to costs in the control group? |